| Summary: | <h4>Objective</h4> <p>Epilepsy is a major public health issue in resource poor settings. Availability and accessibility of antiepileptic drugs (AEDs) remain important issues, which may be aggravated by poor drug quality. Primary objective was to measure the quality of AEDs through official and unofficial supply chain.</p> <h4>Methods</h4> <p>This was a cross-sectional study carried out in Gabon, Kenya and Madagascar. The official and unofficial supply chain have been investigated in urban and rural areas. Oral pharmaceutical forms were collected in structures where a patient could buy or obtain AEDs. Pharmacological analytical procedures were used to assess quality. Medicine Quality Assessment Reporting Guidelines were used.</p> <h4>Results</h4> <p>In total, 102 batches were sampled representing 3782 units of AEDs. Overall 32.4% of the tablets were poor quality, but there was no statistical difference across the sites: 32.4% (26.5% in Gabon, 37.0% in Kenya and 34.1% in Madagascar; p=.7). Carbamazepine had the highest proportion of poor pharmaceutical features in 38.7% (p=.01). Sodium valproate and phenytoin had the poorest quality (p<.001). Phenobarbital (94.5%) and diazepam (100.0%) had better quality (p<.001). Facilities from the public system were associated with presence of substandard (OR, 9.9; p<.04) as well manufacturing in China (OR, 119.8; p<.001). Phenytoin and exposure to atmosphere were associated with a risk of encountering drugs with bad quality (OR, 3.3; p<.007 / OR, 5.4; p<.03).</p> <h4>Significance</h4> <p>Even if countries import good and efficient drugs on their market, they might become ineffective and dangerous by inappropriate storage conditions. </p>
|
|---|